Immunovaccine Publishes Clinical Results with DPX-Survivac in Combination with an Immune-Modulating Compound
Safety and immunogenicity data from Phase 1 trial with company’s lead cancer immunotherapy candidate published in Oncoimmunology
Halifax, Nova Scotia; July 2, 2015 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced that data from its completed Phase 1 clinical trial with lead cancer immunotherapy candidate, DPX-Survivac, was published in the peer reviewed journal Oncoimmunology. The manuscript “Survivin targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients,” which was published in the Friday June 26, 2015 edition of the journal, outlines the safety and immunogenicity of DPX-Survivac when combined with a low dose of cyclophosphamide taken orally by patients.
This work shows that the combination immunotherapy of the DPX-Survivac vaccine and metronomic cyclophosphamide was highly immunogenic in individuals with high-risk ovarian cancer. Immune responses were generated in almost all study participants. Both high-magnitude and polyfunctional survivin-specific T cells were induced. These highly functional T cells produced several well-known activation markers and were detected in the blood of individuals with ovarian cancer as early as 21 days following vaccination. In a follow on study that will be published in the future, one patient with measurable and stable disease achieved a 43 percent reduction in tumor size, demonstrating a durable clinical benefit associated with the DPX-Survivac therapy.
“Immunovaccine is committed to evaluating DPX-Survivac in combination with other best-in-class immune-modulating agents,” said Marc Mansour, Ph.D., Chief Executive Officer, Immunovaccine. “We plan to leverage the ability of our novel vaccine technology to elicit an immune response and our evolving scientific knowledge of immunotherapy to advance promising combination cancer treatments.”
The Phase 1 study evaluated DPX-Survivac in combination with a maintenance low dose oral cyclophosphamide in individuals with ovarian cancer who have responded favorably to a standard of care platinum-based chemotherapy. The dose of cyclophosphamide was designed to have an immune modulation rather than a chemotherapeutic effect. Study participants were enrolled in a non-randomized, dose escalation fashion to receive three doses of DPX-Survivac alone or the vaccine along with cyclophosphamide. Almost all study participants receiving the therapy produced robust T cell responses, with the highest responses appearing in participants who also received cyclophosphamide. The combination of DPX-Survivac and oral cyclophosphamide was generally well tolerated with no significant systemic adverse events.
This newly published clinical trial data were preceded by a detailed preclinical study, which was published in Oncoimmunology in November 2014, demonstrating that the same immunotherapy combination resulted in a better anti-tumor effect in a mouse cancer model.
“The future of cancer treatment lies in rationally developing combination immunotherapy that can both generate cancer specific T cells and reduce the cancer-mediated immune inhibitory mechanism,” said Neil Berinstein, M.D., Department of Medicine at the University of Toronto and the lead author of this study. “Combining complementary immunotherapies is going to become increasingly important in the management of many malignancies.”
This DPX-Survivac-based therapy has been incorporated into a recently initiated Phase 2 clinical trial in individuals with recurrent lymphoma. A randomized Phase 2 clinical trial in advanced ovarian cancer with no measurable disease following initial surgery and platinum-based therapy is also planned. Immunovaccine has been granted U.S. Food & Drug Administration Fast Track designation for DPX-Survivac in this indication.
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. The National Cancer Institute (NCI) has recognized survivin as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in solid tumors and blood cancers including ovarian, breast, colon and lung cancers, among others. Survivin plays an essential role in antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in high percentage of cancer patients.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides on HLA class I molecules. This targeted therapy attempts to use the immune system to actively search for tumor cells expressing survivin and destroy them.
Immunovaccine Inc. develops cancer immunotherapies and infectious disease vaccines based on the Company’s DepoVax™ platform, a patented formulation that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 2 study with its lead cancer vaccine therapy, DPX-Survivac, in recurrent lymphoma. DPX-Survivac is expected to enter additional Phase 2 clinical studies in ovarian cancer and glioblastoma (brain cancer). The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV) and anthrax.
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This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future, is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
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